Hyperbaric oxygenation during radiotherapy did not improve survival in patients with advanced neoplastic disease.

 

Clinical Bottom Line:

1.      The addition of hyperbaric oxygen did not improve survival.

 

Appraised by: Mike Bennett, Dept. of Diving and Hyperbaric Medicine, Prince of Wales Hospital

Sydney; Saturday, 12 December, 1998

 

Clinical Scenario: A patient with advanced neoplastic disease suitable for radiation therapy.

Three-part Question: In patients with advanced neoplastic disease where radiotherapy is the indicated treatment, does administration of hyperbaric oxygen at the time of irradiation, compared to irradiation alone, result in any improvement in survival?

Search Terms: Hyperbaric oxygenation, radiotherapy.

 

The Study:

Non-blinded randomised controlled trial with intention-to-treat.

Advanced neoplastic disease including head and neck (T3, T4, N1-3, Mo), cervix (IIIA, IIIB, IV), bladder (C,D), recurrent rectal (Duke's C), oesophagus and brain. Radiotherapy prescribed.

Control group (N = 24; 24 analysed): 'Normal' 5 day, 1000 rad/week fractions to give total dose usual for the particular tumour. Exact doses not given.

Experimental group (N = 25; 25 analysed): As above but each treatment given in hyperbaric conditions at 3ATA on 100% oxygen for about 50 minutes.

 

The Evidence:

Outcome

Time to Outcome

Radiation Rate

HBO Rate

Relative risk reduction

Absolute risk reduction

Numbers needed

Death

1 year

0.37

0.40

-4%

-0.025

40

95% CI:

 

 

 

-48% to 40%

-0.30 to 0.25

NNH=3 to INF    NNT=4 to INF

Survival

2 years

0.333

0.320

4%

0.013

77

95% CI:

 

 

 

-75% to 83%

-0.25 to 0.28

NNT=4 to INF    NNH=4 to INF

 

Comments:

1. Survival in individual tumour groups did not differ between control and hyperbaric arms.

2. Study terminated prematurely following an explosive decompression.

3. Power low, particularly for individual tumour types.

4. It is not clear what dose of oxygen or radiation each patient received.

 

Expiry date: January 2004

References:

1. Tobin DA, Vermund H. A randomised study of hyperbaric oxygen as an adjunct to regularly fractionated radiation therapy for clinical treatment of advanced neoplastic disease. Am J Roentgenol Radium Ther Nucl Med. 1971; 3:613-621.

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